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FDA Must Fix Process That OK’d Advisory Panel Member Giving Advice at Pharmaceutical Industry Conference

Oct. 30, 2013

FDA Must Fix Process That OK’d Advisory Panel Member Giving Advice at Pharmaceutical Industry Conference

Advisory Panel Member Withdrew From Conference, But Agency Must Create Policies to Prevent the Next Ethics Problem

WASHINGTON, D.C. – The withdrawal of a U.S. Food and Drug Administration (FDA) advisory panel member from a pharmaceutical industry conference is welcome, but the FDA still has not instituted policies to ensure that such a conflict of interest does not happen again, Public Citizen said in a letter to the agency today.

Dr. Lynn Drake, the current chairperson of the FDA Dermatologic and Ophthalmic Drugs Advisory Committee, was scheduled to participate in a pharmaceutical industry conference in February 2014, speaking in a session on “Pitfalls to Avoid as You Prepare for, and Present to, an Advisory Committee.” Last week, Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group, wrote to the FDA, saying Drake’s participation in the event undermines the FDA advisory committee process, and calling for Drake to revoke participation or remove herself from the advisory panel. Participation in such a conference, particularly in a role giving advice to pharmaceutical companies, raises concerns that the advisory committee member is approaching the work of the committee from a pro-industry perspective, Wolfe said.

Drake withdrew from the event. News reports revealed that the FDA had OK’d Drake’s participation, even though the agency didn’t know exactly what it was approving. The FDA said, “Dr. Drake did contact FDA prior to accepting an invitation to the conference; FDA did not signal a concern, but our response was based on limited information.”

The episode shows that the agency does not have adequate policies in place to prevent conflicts of interest that can undermine public confidence in FDA advisory committees.

“If a policy exists that covers this kind of circumstance, it is grossly inadequate, since it allowed a green light for Dr. Drake’s participation in this meeting – participation that likely would have occurred had we not brought these details to the FDA’s attention,” Wolfe said. “It is essential that current FDA policy regarding the ethics of such programs be explicit so that this situation does not recur.”

The letter to FDA commissioner Margaret Hamburg is available at https://www.citizen.org/our-work/health-and-safety/articles/follow-letter-fda-commissioner-hamburg-about-fda-advisory.

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.